Intradermal AIV001 Found Safe in Early BCC Study

The phase 1/2 multicenter study of AIV001 (axitinib) demonstrated excellent skin tolerability and a dose-response.

AiViva Biopharma Inc. completed its first trial administering AIV001 (axitinib) to patients diagnosed with basal cell carcinoma (BCC) tumors. 

AIV001 is intradermally administered and designed for local, prolonged treatment effect for dermatological conditions.

The phase 1/2 multicenter, open-label clinical trial evaluated AIV001 in patients with superficial, nodular or mixed BCC tumors. The study enrolled a total of 26 subjects who were studied in four ascending dose cohorts. Subjects receive up to three treatments during the study and monitored for safety, skin tolerability, and efficacy measured by clinical and histological clearance of malignant basal cells in the lesions. 

“We are excited to have completed this safety study that is demonstrating excellent skin tolerability and a dose response. This promising data allows AiViva multiple options to develop it further, including but not limited to seeking a strategic partner for this compound,” says Diane Tang-Liu, PhD, President and CEO of AiViva, in a news release.

Current treatment often requires surgery that can lead to scarring. “It is exciting and important to have AiViva Biopharma develop a drug, with a new mechanism of action, that has the potential to treat BCC that avoids surgery,” says Brian Berman, MD, PhD, Professor Emeritus of Dermatology and Dermatologic Surgery at The University of Miami Miller School of Medicine.